US-based Exosome Diagnostics has introduced its ExoDx Prostate (IntelliScore) test (EPI) to help rule out high-grade prostate cancer.
EPI is a laboratory-developed test to provide information for an improved prostate biopsy decision-making process.
The test examines a urine sample to detect three biomarkers on exosomal RNA (exoRNA) that are expressed in men with high-grade prostate cancer.
It then uses a proprietary algorithm combined with the relative weighted expression of the three-gene signature to provide physicians a score to help evaluate their patient’s risk for high grade, potentially more aggressive prostate cancer.
The EPI test is intended to facilitate a reduction in unnecessary prostate biopsies and the associated overtreatment of low-grade disease.
Unnecessary tissue biopsies result in discomfort and temporary incontinence or impotence, as well as hospitalisation for serious infections.
University of California chair of urology and EPI clinical validation trial investigator Peter Carroll said: “Prostate cancer is really a spectrum of disease.
"Not all patients have the same type of tumour or the same grade of disease.
“Very few men need immediate treatment.
"Repeat PSA testing, PSA / protein based diagnostic tests, MRI scans and now molecular genetic testing with EPI will provide important data to help clinicians, patients and their families make better informed decisions about whether to proceed with an initial prostate biopsy.
“This test launch marks an important step forward in efforts to develop more sensitive markers for assessing the risk of aggressive prostate cancer and the ability to monitor disease progression in a completely non-invasive approach.”
Results of the final clinical evaluation study which enrolled more than 1,500 patients suggested the accuracy of the EPI test to rule out the presence of high-grade cancer before an initial prostate biopsy.